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Reducing Pregnancy Risks: The Mastery Lifestyle Intervention (MLI)

Primary Purpose

Mental Health Wellness 1, Preterm Birth

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
The Mastery Lifestyle Intervention
Sponsored by
Microgen LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Mental Health Wellness 1 focused on measuring Latina, Pregnancy, Mental Health, Corticotropin Releasing Hormone, Progesterone, Estriol, Gestational age, African American women

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Providing informed consent;
  • Ability to read and speak English or Spanish
  • Pregnant at 14-20 weeks gestation with one fetus, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care
  • Intrauterine pregnancy
  • Self-identification as Latina of Mexican heritage
  • Age 18 to 45 years
  • Born in Mexico or U.S. born and currently living in the U.S.
  • Medicaid or other government supported insurance
  • Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or > on the Perceived Stress Scale as administered by clinical staff of the participating provider
  • Willingness to adhere to the MLI regimen or usual care regimen
  • Women who develop GDM after enrollment in the study will remain in the study. °Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes.

Exclusion Criteria:

After initial review of the electronic health record (EHR):

  • Major systemic infections such as HIV, hepatitis
  • <18 years of age
  • Enrollment in a prenatal program such as the Nurse Family Partnership
  • Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol
  • Inability to read English or Spanish

Sites / Locations

  • Anthony Chavez, MDRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

MLI Experimental group

Control usual prenatal care

Arm Description

6 group sessions over 6 weeks with pregnant Latinas and African Americans starting at 14-20 weeks to 20-26 weeks in their prenatal care setting.

Only data collection but no intervention

Outcomes

Primary Outcome Measures

Anxiety
Self Report questionnaire GAD-7
Depression
Self Report questionnaire CES-D
Stress
Self Report questionnaire-PSS
Coping levels
Self Report questionnaire The Brief Cope

Secondary Outcome Measures

To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of preterm birth (Corticotropin Releasing Hormone (CRH).from baseline to end-of treatment.
Corticotropin Releasing Hormone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
To explore the effect of the MLI, versus a usual care group, on neuroendocrine risk factors (progesterone) on preterm birth from baseline to end-of treatment.
Progesterone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.
Estriol is part of the maternal fetal response to stress, anxiety, and depressive symptoms.

Full Information

First Posted
July 27, 2021
Last Updated
February 9, 2023
Sponsor
Microgen LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05012072
Brief Title
Reducing Pregnancy Risks: The Mastery Lifestyle Intervention
Acronym
MLI
Official Title
Reductions in Biopsychosocial Risks for Pregnant Latinas and Their Infants: The Mastery Lifestyle Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2021 (Actual)
Primary Completion Date
December 20, 2025 (Anticipated)
Study Completion Date
February 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Microgen LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This randomized controlled trial will test an intervention called the Mastery Lifestyle Intervention (the MLI) that was developed from data of 1000+pregnant Hispanic women related to risks of preterm birth. The investigators will deliver a psychoeducational intervention that is manualized over 6 group sessions. The investigators will also have a usual care group that receives standard prenatal care. The investigators plan to enroll 221 pregnant women and start the study with them at 14-20 weeks gestation. The investigators will also test the biological response of the intervention by measuring Corticotropin Releasing Hormone, progesterone, estriol, and test for cotinine. The investigators will also determine any effect on infant outcomes at delivery.
Detailed Description
To address the gaps related to interventions for Hispanic Mexican American and African American pregnant women, the investigators have developed and successfully pilot tested the Mastery Lifestyle Intervention (MLI): a culturally-relevant, manualized psychosocial group intervention that integrates two evidence-based behavioral therapies - Acceptance and Commitment Therapy (ACT) and Problem-Solving Therapy (PST). The MLI is a 6-week program designed to be integrated into regular prenatal care to facilitate more comprehensive care delivered by a nurse practitioner (NP) or certified nurse midwife (CNM). We propose the following hypotheses for a randomized controlled trial: Hypothesis 1a: Participants in the 6-week MLI will have decreased depressive symptoms, anxiety, stress, disengaged coping, and increased active coping compared to UC at end-of-treatment and after 6 weeks. Hypothesis 1b: The effects of MLI versus UC on depression, anxiety, stress, acculturative stress, and coping will be mediated via psychological flexibility and moderated by acculturation. Hypothesis 2a: Compared to UC, MLI participants will have significantly lower mean levels of CRH over time from baseline to end-of-treatment. Hypothesis 2b: Compared to UC, MLI participants will have significantly higher progesterone levels and lower estriol levels (higher progesterone/estriol ratios) over time from baseline to end-of-treatment. Hypothesis 3: As compared to UC, infants from mothers in the MLI group will have longer gestational age, greater birth weight, and fewer NICU admissions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Health Wellness 1, Preterm Birth
Keywords
Latina, Pregnancy, Mental Health, Corticotropin Releasing Hormone, Progesterone, Estriol, Gestational age, African American women

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Usual care group: routine prenatal care by private practice provider Experimental group: Six week group session of the MLI
Masking
InvestigatorOutcomes Assessor
Masking Description
The PI will not be allowed to review any data that is not deidentified. The statistician will also not know which participant is in which group by participant names, only by deidentified data. The clinical outcomes assessor will not know the group the participant has been in or their study number, but will know the participant names to be able to put the clinical outcomes in the database.
Allocation
Randomized
Enrollment
221 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MLI Experimental group
Arm Type
Experimental
Arm Description
6 group sessions over 6 weeks with pregnant Latinas and African Americans starting at 14-20 weeks to 20-26 weeks in their prenatal care setting.
Arm Title
Control usual prenatal care
Arm Type
No Intervention
Arm Description
Only data collection but no intervention
Intervention Type
Behavioral
Intervention Name(s)
The Mastery Lifestyle Intervention
Intervention Description
Combination cognitive behavioral intervention of phase 3 CBT using ACT and PST
Primary Outcome Measure Information:
Title
Anxiety
Description
Self Report questionnaire GAD-7
Time Frame
Assessing change over time: 14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Title
Depression
Description
Self Report questionnaire CES-D
Time Frame
Assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Title
Stress
Description
Self Report questionnaire-PSS
Time Frame
Assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Title
Coping levels
Description
Self Report questionnaire The Brief Cope
Time Frame
Assessing change over time:14-20 weeks, 20-26 weeks, 32-36 weeks pregnant
Secondary Outcome Measure Information:
Title
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of preterm birth (Corticotropin Releasing Hormone (CRH).from baseline to end-of treatment.
Description
Corticotropin Releasing Hormone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Time Frame
Assessing change over time:14-20 weeks gestation, 20-26 weeks gestation
Title
To explore the effect of the MLI, versus a usual care group, on neuroendocrine risk factors (progesterone) on preterm birth from baseline to end-of treatment.
Description
Progesterone is part of the maternal fetal responses to stress, anxiety, and depressive symptoms.
Time Frame
Assessing change over time:14-20 weeks gestation, 20-26 weeks gestation
Title
To explore the effect of the MLI, versus a usual care group, on the neuroendocrine risk factor of Estriol.
Description
Estriol is part of the maternal fetal response to stress, anxiety, and depressive symptoms.
Time Frame
Assessing change over time:14-20 weeks gestation, 20-26 weeks gestation
Other Pre-specified Outcome Measures:
Title
To explore the effect of the MLI on infant gestational age at birth
Description
Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.
Time Frame
After delivery
Title
To explore the effect of the MLI on infant birthweight
Description
Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.
Time Frame
After Delivery
Title
To explore the effect of the MLI on infants being admitted to the Neonatal Intensive Care Unit
Description
Health outcomes of the infants after usual care or after treatment with the intervention to further determine efficacy.
Time Frame
After Delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Providing informed consent; Ability to read and speak English or Spanish Pregnant at 14-20 weeks gestation with one fetus, gestational dating will be reviewed before enrollment via ultrasound administered per standard of care Intrauterine pregnancy Self-identification as Latina of Mexican heritage or African American Age 18 to 45 years Born in Mexico or U.S. born and currently living in the U.S. Medicaid or other government supported insurance Women who score 10 or greater on the Center for Epidemiological Studies Depression Scale (CES-D) OR 5 or greater on the Generalized Anxiety Disorder-7 scale (GAD-7), or 14 or > on the Perceived Stress Scale as administered by clinical staff of the participating provider Willingness to adhere to the MLI regimen or usual care regimen Women who develop GDM after enrollment in the study will remain in the study. °Development of hypertension or preeclampsia, pyelonephritis, or GDM will be considered an effect modifier in analysis of infant outcomes. Exclusion Criteria: After initial review of the electronic health record (EHR): Major systemic infections such as HIV, hepatitis <18 years of age Enrollment in a prenatal program such as the Nurse Family Partnership Severe cognitive or psychiatric impairment per judgment of providers, that precludes cooperation with study protocol Inability to read English or Spanish
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Roberta J. Ruiz, PhD
Phone
2813005265
Email
jruiz@microgenlabs.com
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond P Stowe, PhD
Phone
2814154073
Email
rpstowe@microgenlabs.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roberta J Ruiz, PhD
Organizational Affiliation
Microgen Laboratories LLC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anthony Chavez, MD
City
Houston
State/Province
Texas
ZIP/Postal Code
77054
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberta J Ruiz, PhD
Phone
281-300-5265
Email
jruiz@microgenlabs.com
First Name & Middle Initial & Last Name & Degree
Raymond P Stowe, PhD
Phone
12814154073
Email
rpstowe@microgenlabs.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36577949
Citation
Ruiz RJ, Grimes K, Spurlock E, Stotts A, Northrup TF, Villarreal Y, Suchting R, Cernuch M, Rivera L, Stowe RP, Pickler RH. The mastery lifestyle intervention to reduce biopsychosocial risks for pregnant Latinas and African Americans and their infants: protocol for a randomized controlled trial. BMC Pregnancy Childbirth. 2022 Dec 28;22(1):979. doi: 10.1186/s12884-022-05284-9.
Results Reference
background
PubMed Identifier
31693556
Citation
Ruiz RJ, Newman M, Records K, Wommack JC, Stowe RP, Pasillas RM. Pilot Study of the Mastery Lifestyle Intervention. Nurs Res. 2019 Nov/Dec;68(6):494-500. doi: 10.1097/NNR.0000000000000384.
Results Reference
result
Links:
URL
http://pubmed.ncbi.nlm.nih.gov/31693556/
Description
PubMed

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Reducing Pregnancy Risks: The Mastery Lifestyle Intervention

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